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Moxibustion Plus Cupping in Convalescent Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374084
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : November 24, 2021
Sponsor:
Collaborators:
Hubei Hospital of Traditional Chinese Medicine
Hubei Provincial Hospital of Integrated Chinese & Western Medicine
Wuhan Hospital of Traditional Chinese Medicine
Wuhan Third Hospital
Huangshi Hospital of Traditional Chinese Medicine
Yichang Hospital of Traditional Chinese Medicine
Ezhou Hospital of Traditional Chinese Medicine
The First Hospital of Hunan University of Chinese Medicine
The Hospital of Jiangxi University of Chinese Medicine
Information provided by (Responsible Party):
Xiaopin Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Convalescence Other: Moxibustion plus Cupping Not Applicable

Detailed Description:
Moxibustion plus cupping may be effective and safe for convalescent patients with COVID-19, but evidence is limited. The randomized clinical trial may help to provide evidence-based factors for improving the patients' symptoms in the convalescence of COVID-19.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Moxibustion Plus Cupping in Convalescent Patients With COVID-19: A Randomized Clinical Trial
Actual Study Start Date : May 10, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moxibustion plus Cupping

Moxibustion plus cupping and basic therapy (rehabilitation direction and basic breathing exercise) once a day for 4 weeks (28 sessions).The moxibustion plus cupping treatments were divided into 2 alternating formulas:

A: Monday, Wednesday, Friday and Sunday: moxibustion on bilateral Fengmen (BL12), Feishu (BL13) and Pishu(BL20) B: Tuesday, Thursday and Saturday: moxibustion on Zhongwan (RN12), Qihai (RN6), bilateral Tianshu(ST25) and Zusanli(ST36) + cupping on bilateral Feishu(BL13) Geshu(BL17) Pishu(BL20) The 2 formulas were used alternatively every other day, 7 times per week, for 4 weeks. Moxibustion acupoint addition: profuse sweating added Fuliu (KI7), insomnia added Shenmen(HT7) anxiety or depression added Neiguan (PC6).

Other: Moxibustion plus Cupping
Moxibustion: The burning of a small, thimble sized, smoldering plug of dried leaves on the skin at an acupuncture point. Usually the plugs contain leaves of mugwort or moxa. Cupping takes the pot as a tool, uses the combustion to remove the air in the pot, causes a negative pressure, and makes it adsorb on the skin of the acupoints. Use"Baixiaojiu"moxibustion on each acupoint for 10-15 minutes, the temperature of moxibustion should be adjusted within patient's tolerance level. Use diameter of 5-6 cm acuum cupper to cupping on each acupoint for 5-8 minutes.

No Intervention: Basic therapy
Basic therapy: rehabilitation direction and basic breathing exercise.



Primary Outcome Measures :
  1. The proportion of responder at week 4 [ Time Frame: baseline, week 4 ]
    The responder is defined as the participants with ≥ 50% average VAS decrease of chest tightness and fatigue compared with baseline. The VAS ranges from 0 to 100.


Secondary Outcome Measures :
  1. The proportion of responder at week 8 [ Time Frame: baseline, week 8 ]
    The responder is defined as the participants with ≥ 50% average VAS decrease of chest tightness and fatigue compared with baseline. The VAS ranges from 0 to 100.

  2. The change in the average VAS score of main symptoms from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the change in the average VAS score of main clinical symptoms (chest tightness, fatigue, short of breath and cough) will be assessed from baseline. VAS ranges from 0-100.

  3. The change in the severity VAS score of main symptoms from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the change in the severity VAS score of main clinical symptoms (chest tightness, fatigue, short of breath and cough) will be assessed from baseline. VAS score ranges from 0-100.

  4. The change in the average VAS score of other symptoms from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the change in the average VAS score of other symptoms (insomnia, sweating, mental fatigue, inappetence, mental stress) will be assessed from baseline. VAS score ranges from 0-100.

  5. The change in mean frequency of diarrhea and spontaneous bowel movements from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the change in mean frequency of diarrhea and spontaneous bowel movements in the past 1 week will be assessed from baseline.

  6. The proportion of participants with ≥50%/75% improvement of VAS from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the proportion of participants with ≥50%/75% VAS change of clinical symptoms (chest tightness, fatigue, short of breath, cough, insomnia, sweating, mental fatigue, inappetence, mental stress) will be assessed. VAS score ranges from 0-100.

  7. The change of the walking distance of six-minute-walking test from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the walking distance of six-minute-walking test changed from baseline.

  8. The change of the lowest oxygen saturation of six-minute-walking test from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the lowest oxygen saturation of six-minute-walking test changed from baseline.

  9. The proportion of patients in recovery of pulmonary function at week 4 [ Time Frame: baseline, week 4 ]
    At the end of week 4, the proportion of patients in recovery of pulmonary function in all participants.

  10. The proportion of patients whose lung CT return to normal at week 4 [ Time Frame: baseline, week 4 ]
    Lung CT shows complete absorption of inflammation.

  11. The change of the WHO QOL-BREF score from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the WHO Quality of Life-BREF (WHO QOL-BREF) score changed from baseline. WHO QOL-BREF ranged from 4 to 20 with higher scores as the better quality of life.

  12. The change of the SAS score from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the Self-Rating Anxiety Scale (SAS) score changed from baseline. The standard SAS ranged from 25 to 100 with higher score as the worse anxiety.

  13. The change of the SDS score from baseline [ Time Frame: baseline, week 4, week 8 ]
    At the end of week 4 and week 8, the Self-Rating Depression Scale (SDS) score changed from baseline.The standard SAS ranged from 25 to 100 with higher score as the worse depression.

  14. The change of the blood CRP/LYMPH#/NEUT% value from baseline [ Time Frame: baseline, week 4 ]
    At the end of week 4, the blood C-reactive protein (CRP) value, blood lymphocyte count (LYMPH#) and the percentage of blood neutrophils (NEUT%) value will be assessed compared with baseline.

  15. subtype analysis [ Time Frame: baseline, week 4 ]
    Subtype analysis of age (≤40 years old, >40 years old), gender (male, female), and severity of the disease (mild, moderate, heavy, critical) will be performed in the primary outcome.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of the convalescence of COVID-19 (defined by the Chinese Guideline for COVID-19 in 2020 Trial Version 7).
  2. 18-70 years old;
  3. chest tightness/fatigue/shortness of breath/cough, with at least 2 of the above symptoms and the average VAS score (last 48 hours) ≥ 40 points;
  4. Volunteers with informed consent;

Exclusion Criteria:

  1. Surgery in the lung that affects lung function;
  2. Rely on mechanical ventilation to maintain lung function;
  3. Chronic lung diseases affecting lung function;
  4. Diseases affecting heart function;
  5. Severe basic diseases;
  6. Resting heart rate > 120/min, systolic blood pressure > 180mmHg, diastolic blood pressure > 100mmHg;
  7. Unstable angina or myocardial infarction in the past 1 month;
  8. Severe obesity (BMI>30kg/m2);
  9. Allergic constitution;
  10. Pregnant or lactating women;
  11. Disabled patients;
  12. Mentally ill Patients;
  13. Participating in other clinical trials;
  14. Poor compliance or other complicate conditions according to the researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374084


Contacts
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Contact: Jiani Wu +86 13426116653 handsom_mars@126.com

Locations
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China, Hubei
Hubei Province Hospital Recruiting
Wuhan, Hubei, China
Contact: Zhongyu Zhou    +86 18672308659    2209447940@qq.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Hubei Hospital of Traditional Chinese Medicine
Hubei Provincial Hospital of Integrated Chinese & Western Medicine
Wuhan Hospital of Traditional Chinese Medicine
Wuhan Third Hospital
Huangshi Hospital of Traditional Chinese Medicine
Yichang Hospital of Traditional Chinese Medicine
Ezhou Hospital of Traditional Chinese Medicine
The First Hospital of Hunan University of Chinese Medicine
The Hospital of Jiangxi University of Chinese Medicine
Investigators
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Principal Investigator: Xiaopin Wang Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Principal Investigator: Zhongyu Zhou Hubei Hospital of Traditional Chinese Medicine
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Responsible Party: Xiaopin Wang, Secretary of Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04374084    
Other Study ID Numbers: 2020YFC0845000
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data are available on reasonable request. You can send e-mail to us if you have any question.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: It depends.
Access Criteria: It depends.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaopin Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Moxibustion
COVID-19
Randomized Clinical Trial
Additional relevant MeSH terms:
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COVID-19
Convalescence
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes